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Job Location | Hanover, ON |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Full Time |
We are a global team of 6000 visionaries, doers, and makers. Our portfolio of over 25 brands touches lives in more than 50 countries. Together, we reimagine good mornings and endless summers, beauty and bonding, confidence and determination.Position SummaryThe primary responsibility of the Quality Manager is to ensure continuing excellence and compliance in the Quality system across all the regulated sites in Canada which includes Milton (Distribution) and Hanover (Packaging) The incumbent will ensure ongoing compliance with all applicable regulations, ensure all compliance plan deliverables are achieved, maintain all operations in full inspection-ready fashion, foster a mindset of continuous quality improvement, and be a leading voice in sustaining a culture of excellence. Responsible for managing, coaching, and inspiring a high performing Quality team.Universal AccountabilitiesEnsure compliance with all Health Canada, and GMP requirements for OTC, Cosmetics, and Devices.Ensure that quality systems are implemented and followed in Milton and Hanover (e.g. temperature monitoring, calibration program, document control, product testing, specifications, control procedures, etc.).Release of Finished Goods and/or Raw Materials.Prioritize and direct the work of Quality personnel and communicate timetables and standards of excellence regularly to ensure commitments are met.Lead the quality team by providing coaching, motivation, and direction. Model the organization’s values and behaviors and engage the team to do the same.Plan and implement Quality strategies, policies, and objectives in accordance with Company strategic plans (SOPs).Provide growth and development for the team and work to have successors in place.Actively participate in Regulatory and Internal Inspections.Escalate to upper management any issue that potentially can impact release of product to market.Collaborate with multidisciplinary teams.Champion the quality culture and build outstanding partnerships with operations, supply chain, regulatory, commercial, and other functions based on mutual candor and continual bidirectional learning.Specific AccountabilitiesIncumbent is responsible for the release of all imported product.Is the primary contact for interactions with Health Canada.Provides input and manages against a planned budget.Must stay current and be well-versed in all aspects of all applicable regulations.Ensure that personnel are properly trained to successfully accomplish job duties and responsibilities.Responsible to respond to all inspections and ensure all applicable actions are taken to ensure compliance.Frequent travel to Hanover.Required Skills and ExperienceBachelor of Sciences degree with at least 10 years of experience in leading Quality Systems and Inspections in Canada with direct accountability for product release and HC accountability in Cosmetic/Drug/NHP/Med Devices.Full command of GUI-001Expert knowledge of ISO 13485:2016 and ISO 22716:2007Knowledge of FDA, ICH guidelines.Knowledge of safe work practices and Ontario Health and Safety Act.Proficient with various computer software programs and use of audiovisual tools.Preferred Skills and ExperiencesWorking knowledge of Distribution and Packaging of imported products in Canada.Working knowledge of Canadian Medical Device Regulations SOR/98-282.Results oriented analytical thinker with strong problem -solving abilities.Collaborative in approach with the ability to influence the decision-making process.Excellent interpersonal and communication skills at all levels both within and outside the organization.Strong initiative and organizational and project management skills.Ability to successfully work within and promote a team environment.Working Relationships